Quality Specialist

About us

Since our inception, Blossom Innovations / Avava Medical has been rooted in deep expertise, unmatched success, and continual collaboration. Founded by some of the most celebrated names in dermatology, today we’re at the forefront of clinical innovation — with seasoned executive leadership, a growing team of dedicated R&D experts, and a dynamic network of industry and research collaborations.

Avava, a subsidiary of Blossom Innovations, developed a breakthrough in spatially selective laser treatment. Our innovation team is expanding and looking to hire a Quality Engineer to play a key role in development of laser-based medical devices.

Quality Specialist

Job Summary:

The QA Specialist performs quality activities in support of new product production and product releases. The position involves interactions with different internal departments, including Manufacturing and Engineering. The position may also have interactions with external entities including contractors, suppliers, and customers. The QA Specialist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting audits, training programs, data analysis, and documentation reviews.

Key Responsibilities:

· Inspect incoming raw materials, in-process assemblies, and finished Medical Devices.

· Review and approve product DHRs. Identify discrepancies and work to obtain resolution of the discrepancies with the responsible individual.

· Review quality related paperwork for accuracy and completeness. Identify discrepancies and work to obtain resolution of the discrepancies with the responsible individual.

· Manage the Document Control and Change Control processes.

· Perform New Hire GMP Training; and maintain QA Training Program/Database and Training Records.

· Participate in departmental and interdepartmental meetings to help resolve product/process issues.

· Prepare and update Quality documents. Review and approve interdepartmental documents to ensure conformance with the regulations and guidelines.

· Support the Director of Quality on various projects and process improvements.

Skills and Competencies:

· Ability to read and understand SOPs and part inspection drawings.

· Attention to detail and a proactive and constructive approach to resolving discrepancies is required.

· Must have good communication skills, both written and verbal.

· Ability to meet deadlines that are set, and rearrange priorities if needed, to meet commitments.

· Must have the ability to work both independently and also as part of a team.

· Ability to make revisions to department documents, with limited assistance.

· Ability to work on multiple projects simultaneously.

· Must be able to analyze a situation to determine the variables that influence decision-making.

· Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

· Normally receives no instructions on routine work, and general instructions on new assignments.

· Recognizes problems and is able to communicate issues to others with technical expertise for prompt resolution.

· Possesses and applies appropriate knowledge of procedures and protocols necessary to complete tasks.

· This person sometimes needs to collaborate with others on more complex procedures.

· Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Preferred Education and Experience:

2-5 years of related experience in a GMP/GLP regulated / medical device environment and a demonstrated knowledge of ISO13485 principles.

Organizational Relationship:

The Quality Specialist reports to the Director of Quality.

Job Type: Full-time

Pay: $85,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Experience level:

• 5 years

Schedule:

• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Education:

• Bachelor's (Preferred)

Experience:

• Quality control: 2 years (Required)
• Product development in FDA regulated environment: 2 years (Required)
• quality/regulatory experience in medical devices: 2 years (Required)
• FDA, ISO, EUMDR in medical device: 2 years (Required)

Work Location: In person